Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity

This study has been completed.
Sponsor:
Collaborator:
University of Malaya
Information provided by (Responsible Party):
Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:
NCT01665482
First received: August 12, 2012
Last updated: August 14, 2012
Last verified: August 2012

August 12, 2012
August 14, 2012
March 2012
July 2012   (final data collection date for primary outcome measure)
  • Interleukin-6 [ Time Frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18. ] [ Designated as safety issue: No ]
  • C-peptide [ Time Frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01665482 on ClinicalTrials.gov Archive Site
hsCRP [ Time Frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity
Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity

Rationale: It is well established that increased intake of saturated fatty acids (SFA) is associated with incidence of cardiovascular heart disease (CHD). This effect is mediated by dietary saturated fat's impact on fasting plasma cholesterol levels. Research is needed to clarify the association between dietary fatty acids and metabolic risk markers beyond lipid profile. World Health Organisation (WHO) has recommended reduced intake of SFA with energy replacement from monounsaturated fatty acids (MUFA) or carbohydrates (CARB). However, limited evidence is available on the effects of dietary fatty acids on insulin sensitivity and secretion. The current study is designed to investigate the effects of SFA versus MUFA versus CARB on insulinemic response and lipid metabolism in healthy individuals with central obesity.

Study design: A randomized, crossover, single blind design study was carried out. The subjects consumed controlled diets for 6 weeks each. They were provided 3 meals per day during weekdays in which SFA, MUFA and CARB diet was assigned to them randomly. Protein content was standardised at 14% energy. The SFA and MUFA diets each provided 31.5% energy intake from fat, with 69% of the total fats replaced by test fats (approximately 49 g/d based on a 2000 kcal basic diet). Each individual fatty acid provided approximately 7% of the total energy intake. The CARB diet provided approximately 34 g/day experimental fat based on a 2000 kcal basic diet. The CARB diet replaced 7 % energy of carbohydrate from total fat with the exchange from oleic acid (C18:1).

Hypothesis: Changing energy from dietary fat (SFA and MUFA) to carbohydrate will influence insulin sensitivity, endothelial and vascular function, pro-inflammatory markers and lipid metabolism differently in individuals with metabolic syndrome. SFA (palm olein) may be comparable with MUFA (high oleic sunflower oil) with regards to its effects on insulin sensitivity, endothelial and vascular function and inflammation

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Inflammation
  • Insulin Sensitivity
  • Other: A 2000 kcal test meal
  • Other: A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate
  • Active Comparator: Saturated fat rich diet
    Intervention: Other: A 2000 kcal test meal
  • Active Comparator: Monounsaturated fat rich diet
    Intervention: Other: A 2000 kcal test meal
  • Active Comparator: Carbohydrate/ Low fat diet
    Intervention: Other: A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Abdominally obese males and females (waist circumference > 90 cm for male, > 80 cm for female),
  2. Age 20-60 years

Exclusion Criteria:

  • a medical history of cardiovascular disease, diabetes, dyslipidemia;
  • current use of antihypertensive or lipid lowering medication;
  • plasma cholesterol > 6.5 mmol/L, TAG > 4.5 mmol/L;
  • alcohol intake exceeding a moderate intake (> 28 units per week);
  • pregnancy,
  • smoker and
  • breastfeeding.
Both
20 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Malaysia
 
NCT01665482
PD155/11
Yes
Malaysia Palm Oil Board
Malaysia Palm Oil Board
University of Malaya
Principal Investigator: Teng Kim Tiu, PhD MPOB
Malaysia Palm Oil Board
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP